CAPA closure and the BCR

Hi All
Hope everyone has submitted their compliance report ok and on time.

Question:
The compliance report asks the question in section H relating to CAPADoes the incident/adverse event/deviation procedure specify an expected timescale for investigation and closure of investigations?What is the timescale?please give number of investigations (As at 1/12/2018) that remained 'open' and exceeded the expected closure date by:

At our most recent inspections, we adopted the approach as suggested by the inspector, for when the CAPA is to be considered closed. We have since developed two KPIS:
1) identification of Root cause and identification of the Corrective actions required (7 days)
2) Closure of corrective action against identified designated target date. (default is 28 days but subject to assessment)

Given this, the compliance report is asking two questions and doesn't quite fit with the question(s) we are trying to answer. From a BCR report point of view, at what point is the CAPA closed ie remaining open?
The second issue is our corrective action closure is not set at the same time but dependent on the actions required.

Its caused a bit of discussion here as the Quality view is always that until the Corrective has been implemented the capa isn't closed.

I also think it would be really useful for more extensive guidance notes on the completion of the BCR, so all HBB are answering consistently and therefore enabling MHRA to do a consistent assessment across the UK. For example, at what level is a change considered significant?

I would agree with your Quality colleagues about the capa remaining open until actions are completed. It’s easy to forget to do these things otherwise. Though I am sure others may handle this differently and it would be good to hear from them.Thanks for sharing your practices- may copy your idea of a KPI for initial id of RC and actions.

I fully agree with you about the guidance notes, and this has been raised previously. These need to be written in an easier style and layout with definitions of terminology . Though not sure many of us could cope with having to wade through even more documentation each year

I have emailed Mike Dawe and he has responded (I hope he posts his response on here too!).
If I am understanding his response right, we should have used the date for the RCA closure on the BCR and not the overall CAPA closure. We vary the dates for the corrective actions side based on the severity of the incident.
Out of interest, what do you use?

Hmmmmm......
Well, we use 30days for closure of the full QI= initial corrections, identifying root cause, further correction/ PAs. Most QIs are simple and quick to sort, so it's not an issue, but sometimes there may be a need to extend depending on complexity ie the findings of the RC.... Sometimes the actions may be transferred to a 'to do list' or for adding to low level document improvements (but nothing significant).
I think our definition of QI should be explored- for us this is anything that deviates, errors/ reactions including SAE/SARs, equipment issues, complaints,training, delays, audit NCs, TATs not met, supplier issues, etc..... many don't have complex RC- and can be a quick fix, so the QI ( and associated CAPA) should easily be closed within 30 days. When the 'system' is being stressed by external factors- eg time to perform corrective actions, staff available to help, my being disorganised , going mad etc, then the expected 30day closure will not be met- which will trend as overdue CAPA, and surely that is what the question is trying to assess- overall system health at any given time in the year?
You can even see trends of increasing overdue closures during summer and christmas breaks.

Are we saying the same thing??? - are we all confused now?

That's why I believe we really need some workshops and a consistent approach!

Thanks for taking the time to discuss- the learning never stops for any of us, but its good fun having these chats, and sometimes you just have to laugh!

The handling of incidents consists of a number of steps; the question in the BCR asks about the investigation phase of the incident handling process. What timescale do you allow for the complete your investigations? Your quality representative is correct there must also be a timescale set for the completion of CAPA and procedures to manage this.

It is important to investigate incidents promptly since investigations are likely to rely on the memory of individuals. The most serious categories of incident (based on risk) will also need to have CAPA in place quickly since a further occurrence could have very serious consequences. The investigation of incidents is a key step and therefore a timescale should be set for the reporting of incidents and completion of investigations. Organisations may set up a timescale that would also allow the completion of CAPA for many incidents. CAPA sometimes, however, consist of complex actions and a procedure to manage such CAPA separately from the investigation could be considered in these cases. CAPA should still be carried out according to a timescale but the time period would be justified based on the nature of the actions.

It should be remembered that risk-reducing actions may be necessary at any point after the reporting of an incident; immediate action may be necessary to correct an incident and a requirement for rapid action may also become apparent at any time during an investigation as further details come to light.